Reported Apr 28, 2021 · Terminated
Stopcock rotator (Component)
Smiths Medical ASD Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Smiths Medical ASD Inc. · 6000 Nathan Ln N · Minneapolis, MN · 55442-1690
Is this the product you have?
Stopcock rotator (Component)
3 of 3 products
| Model / number | Product as published |
|---|---|
MX1431MR | 1050 STOPCOCK ROTATOR, OFF HANDLE |
MX1431MRL | 1050 STOPCOCK LEFT ROTATOR, OFF HANDLE |
MX4331R. | 700 PSI STPCK W/ ROTATOR, Stopcocks and manifolds used to control the direction of IV fluid flow. |
- Lot codes and dates
- a. Model Number MX1431MR
- Lot Numbers3995544 b. Model Number MX1431MRL
- Lot Numbers
39955454011838402775840335014044959 c. Model Number MX4331R
- Lot Numbers
39714673987918
- Amount recalled
- 3825 units
This recall covers 12 products
The agency filed one notice per product. You are reading one of them; the other 11 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are components for various cardiac kits including pressure monitoring devices and interventional imaging devices.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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